Not Cleared Direct

DEN210027 - The Cooral System (FDA 510(k) Clearance)

Class II Dental device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210027 · Braincool AB · Dental device
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Oct 2022
Decision
469d
Days
Class 2
Risk

DEN210027 is an FDA 510(k) submission (not cleared) for the The Cooral System. Classified as Intraoral Cooling Device (product code QUA), Class II - Special Controls.

Submitted by Braincool AB (Lund, SE). The FDA issued a Not Cleared (DENG) decision on October 14, 2022 after a review of 469 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5590 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 469 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN210027 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 02, 2021
Decision Date October 14, 2022
Days to Decision 469 days
Submission Type Direct
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
342d slower than avg
Panel avg: 127d · This submission: 469d
Pathway characteristics

Device Classification

Product Code QUA Intraoral Cooling Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5590
Definition An Intraoral Cooling Device Is A Prescription Use Device That Is Intended To Cool The Mouth For Patients At Risk For Oral Mucositis. An Intraoral Cooling Device Consists Of A Removable Mouthpiece And Accessories That Cool Oral Mucosal Surfaces
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.